Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: turoctocog alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00984126

U1111-1111-9377 (Other Identifier)

JapicCTI-101357 (Registry Identifier)

NN7008-3568

2008-005945-46 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.

The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.

The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).

Enrollment

214 patients

Sex

Male

Ages

6 months to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed Consent obtained before any trial-related activities
Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015

Exclusion criteria

Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product